BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMACEM V+ CEMENT KIT 10 ML

    MDR report key: 3831830 · Received May 27, 2014

    Report

    Report Number
    3000270450-2014-10033
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 5, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INITIAL REPORTER PHONE (B)(6). 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING REVIEW WAS PREVIOUSLY DOCUMENTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4)REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE COMPLAINT RECEIVED FROM THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) AUGMENTATION STUDY REPORTED THAT DURING CEMENT INJECTION THERE WAS LEAKAGE OF THE CEMENT. THE ONLY DOCUMENTED INTERVENTION WAS "FURTHER INJECTION IMMEDIATELY STOPPED". THE STUDY DOCUMENT INDICATED THERE WAS NO POST-OPERATIVE ADVERSE EVENT NOTED FOR THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311624 TRAUMACEM V+ CEMENT KIT 10 ML FILLER, BONE VOID, CALCIUM COMPOUND MQV SYNTHES SELZACH 2B53050

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR